There are a few tips in preparing a Pre-Market Tobacco Application (PMTA). Since the September 9, 2020, PMTA deadline for e-cigarettes (also known as Electronic Nicotine Delivery Systems (ENDS)) and e-liquids my firm has filed over 40 PMTAs. Below are a few tips on filing a PMTA, which I recently shared with Avomeen (link here).
The top and most important components of a PMTA submission according to Marc Sanchez is a literature review in lieu of clinical data, the analytical testing component, an environmental assessment and information in various modules describing the device (or e-liquid) and providing any necessary details or specifications in regards to manufacturing.
The manufacturer too is a key part in submitting a PMTA. “Working with manufacturers has definitely been a learning curve. There are good manufacturers who communicate extremely well, provide necessary information quick and efficiently,” says Sanchez, “Some manufacturers are a lot slower and need more handholding which can slow down your submission.” A lot of details come from the manufacturer including specifications or schematics related to your product or device, how your product is made from beginning to end, and one of the FDA’s most sought-after pieces of information, how manufacturers control quality.
Sanchez mentions the skepticism towards closed, disposable devices from the FDA, stating that “because they’re newer and the overall marketing towards youth is a big deal. It’s the main difference in an open versus closed device filing.” Youth prevention is one of the main requirements of a closed device filing. Simply because the FDA believes these types of devices are more accessible and attractive to youth, whereas open devices demographics are more of people seeking showmanship or overall vape connoisseurs. However, there are challenges that come with open systems. The unlimited amount of customization, particularly with various modifications or accessories is a variable that worries the FDA.
Filing for e-liquids is completely different than filing for devices and devices sold that include an e-liquid is different than devices altogether. “In an e-liquid application you will have more information and data relating to the formulation, whether it is to be used in an open or closed device and the differences in manufacturing,” says Sanchez. Sanchez also noted that many custom vape shops who create their own blends struggle to submit PMTA’s. Those custom blends or create your own in shops all require PMTAs. As much as it is both challenging and costly, he’s seen it done before.
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